Use of Magtrace Bracketing for Excision of Lesion and Sentinel Lymph Node Localization in Breast Conserving Surgery for Breast Cancer

NCT07844473 | Recruiting

• 1 other identifier: IRB#2261285
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the commonest cancer affecting women worldwide. Early breast cancer is treated surgically with wide local excision of tumor with axillary staging operations like sentinel node biopsy. Surgical adjuncts used in identifying and localizing the area for excision include metallic wire, radioactive or magnetic seeds and radiofrequency reflectors. These are placed in the lesion under image guidance by the breast radiologists, either on the day of surgery (wires) or prior (seeds). Bracketing localization is performed in case of multiple lesions or wide spread calcifications to aid the surgeons in performing wide local excision of all involved areas. This means placing multiple devices around the area of excision for accurate triangulation, which increase the costs significantly. Localization agents like radionucleotide labelled albumin, super paramagnetic iron oxide (SPIO) and colored dyes like methylene blue, isosulphane blue and indocyanine green are injected in the breast for identification of sentinel lymph nodes in the axilla. More recent studies have demonstrated successful use of SPIO in localization of small impalpable breast cancer lesions. This also raises the prospect of using SPIO for the dual purpose of lesion localization / bracketing and sentinel node biopsy. This study was designed to test this principle in patients requiring bracketing. This is a prospective proof-of-concept pilot study to evaluate the feasibility of SPIO (Magtrace®) as a single-agent solution for bracketing the excision area and localizing the sentinel lymph node for breast-conserving surgery. Patients with breast cancer requiring bracketing and sentinel node biopsy will be identified through multidisciplinary breast tumor board and invited to take part in the study. All patients who consent to participate will receive an injection of Magtrace® for bracketing (0.5ml each at four points around the excision area) one day before surgery under ultrasound guidance. Primary outcome will be successful localization of the Magtrace® signal in breast for bracketing and in the sentinel node, using a magnetic probe on the day of surgery. Clinical outcomes, complications and cost analyses will be performed as secondary outcomes. We anticipate a sample size of 35 patients to be recruited for the study.

Conditions

Breast Cancer With Low to Intermediate HER2 Expression; Breast Cancer (Triple Negative Breast Cancer (TNBC)); Breast Cancer (Triple Negative Type); Breast Cancer - Infiltrating Ductal Carcinoma; Breast Cancer - Ductal Carcinoma in Situ (DCIS)

Keywords

Breast cancer; Breast conserving surgery; Sentinel node biopsy; Magtrace; Super paramagnetic iron oxide

Outcome Measures

Primary Outcomes (1)

• Success localization of bracketing Magtrace injection with Magnetic probe

  A hand held magnetic localization probe (Sentimag) will be used on the morning of surgery by the operating surgeon to localize the signal of Magtrace at four points bracketed around the area of the breast to be excised. For the bracketing localization to be considered successful, signal localization will be required to be present at all four points.

  Morning of surgery.

Secondary Outcomes (6)

• Successful sentinel node localization with Magnetic probe

  Time of surgery

• Duration of surgery

  Time of surgery

• Breast tissue resection weight and volume

  Time of surgery

• Resection margin positivity rate (proportion of patient with tumor present at resection margin on final histology)

  2 weeks post surgery.

• Re-operation rates

  3 months

Other Outcomes (2)

• Operator ease of use / acceptability.

  Time of intervention

• Procedure cost analysis

  Time of intervention.

Study Arms (1)

Magtrace Bracketing

EXPERIMENTAL

Patients identified from breast multidisciplinary team meeting who require breast conserving surgery with bracketing required for the area of excision, with sentinel lymph node biopsy simultaneously will be recruited to the study (single intervention arm). Informed consent will be obtained for all patients who agree to take part in the study. Patients who agree to participate will receive Magtrace Injection in the breast one day before surgery. Magtrace will be injected at four points around the area to excised for bracketing.

Other: Super paramagnetic iron oxide bracketing injection

Interventions

Super paramagnetic iron oxide bracketing injection OTHER

Lesion localization procedure will be performed one day before or on the day of surgery. Patients included in the study will have localization of primary cancer / cancers with Magseed® and bracketing with Magtrace® under ultrasound / Mammographic guidance as indicated, in accordance with the local treatment protocol. The Consultant Radiologist using Magtrace® will perform bracketing under image guidance. 0.5ml of Magtrace® will be injected into the breast parenchyma superior, inferior, medial and lateral to the area planned for excision.

Magtrace Bracketing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients with breast cancer undergoing breast conserving surgery requiring bracketing of the area of excision (as determined by the multidisciplinary tumor board) and a sentinel lymph node biopsy for axillary staging.

You may not qualify if:

• Patients having mastectomy.
• Patients unfit for breast conserving surgery due to inability to have adjuvant radiotherapy.
• Patients requiring axillary clearance without sentinel node biopsy.
• Patient undergoing breast conserving surgery without need for sentinel node biopsy.
• Patient with metastatic breast cancer requiring palliative surgery for local control.
• Patients not consenting for research.
• Patient with allergy to Magtrace.

Sponsors & Collaborators

• King Faisal Specialist Hospital & Research Center: lead

Study Sites (1)

King Faisal Specialist Hospital and Research Center

Madinah, Saudi Arabia

RECRUITING

Related Publications (7)

• Da Silva M, Porembka J, Mokdad AA, Seiler S, Huth J, Rivers A, Wooldridge R, Chu A, Brown E, Bao J, Farr D, Hansen M, Unzeitig-Barron A, Leitch M, Rao R. Bracketed radioactive seed localization vs bracketed wire-localization in breast surgery. Breast J. 2018 Mar;24(2):161-166. doi: 10.1111/tbj.12854. Epub 2017 Jul 14.

  PMID: 28707718 BACKGROUND

• Lyons W, Lamm R, Duffner ER, Shames J, Willis AI, Lazar M. Bracketed Localization in Breast-Conserving Surgery: Indications and Success Rates From a Single, High Volume, Academic Breast Cancer Center. Am Surg. 2023 Nov;89(11):4373-4378. doi: 10.1177/00031348221111516. Epub 2022 Jun 27.

  PMID: 35758520 BACKGROUND

• Davis KM, Raybon CP, Monga N, Waheed U, Michaels A, Henry C, Spalluto LB. Image-guided Localization Techniques for Nonpalpable Breast Lesions: An Opportunity for Multidisciplinary Patient-centered Care. J Breast Imaging. 2021 Sep 16;3(5):542-555. doi: 10.1093/jbi/wbab061.

  PMID: 38424951 BACKGROUND

• Cheung BHH, Co M, Lui TTN, Kwong A. Evolution of localization methods for non-palpable breast lesions: a literature review from a translational medicine perspective. Transl Breast Cancer Res. 2024 Apr 15;5:12. doi: 10.21037/tbcr-23-49. eCollection 2024.

  PMID: 38751684 BACKGROUND

• Liberman L, Kaplan J, Van Zee KJ, Morris EA, LaTrenta LR, Abramson AF, Dershaw DD. Bracketing wires for preoperative breast needle localization. AJR Am J Roentgenol. 2001 Sep;177(3):565-72. doi: 10.2214/ajr.177.3.1770565.

  PMID: 11517048 BACKGROUND

• Ahmed M, Anninga B, Goyal S, Young P, Pankhurst QA, Douek M; MagSNOLL Trialists Group. Magnetic sentinel node and occult lesion localization in breast cancer (MagSNOLL Trial). Br J Surg. 2015 May;102(6):646-52. doi: 10.1002/bjs.9800.

  PMID: 25868072 BACKGROUND

• Torras I, Cebrecos I, Castillo H, Mension E. Evolution of breast conserving surgery-current implementation of oncoplastic techniques in breast conserving surgery: a literature review. Gland Surg. 2024 Mar 27;13(3):412-425. doi: 10.21037/gs-23-454. Epub 2024 Mar 14.

  PMID: 38601289 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Fayyaz A Mazari, MBBS, MSc, MS, PhD, FRCS, FEBS

  King Faisal Specialist Hospital & Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fayyaz A Mazari, MBBS, MSc, MS, PhD, FRCS, FEBS

CONTACT

+966 12667 7777; fmazari@kfshrc.edu.sa

Zabihullah Khan, MBBS FRCS

CONTACT

+966126677777; zkhan@kfshrc.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Oncoplastic Breast & General Surgeon

Model Details: Recruitment: Patients will be Identified form breast multidisciplinary tumor board for Inclusion In the study. All patients fulfilling the Inclusion criteria will be invited to take part. Informed consent will be obtained for all patients who agree to take part in the study. Intervention and assessment: Lesion localization procedure will be performed one day before or on the day of surgery. Patients included in the study will have localization of primary cancer / cancers with Magseed® and bracketing with Magtrace® under ultrasound / Mammographic guidance as indicated, in accordance with the local treatment protocol. The Consultant Radiologist using Magtrace® will perform bracketing under image guidance. 0.5ml of Magtrace® will be injected into the breast parenchyma superior, inferior, medial and lateral to the area planned for excision. The operating surgeon will review patient on the day of surgery and localization of bracketing Magtrace® will be performed using Sentimag probe.

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 28, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2029
• Last Updated: September 28, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study protocol and informed consent form will be available from the beginning to the end of study and afterwards. Dataset will be available from the end of recruitment to the end of study.
• Access Criteria: All parties with access to ClinicalTrials.gov wil have access to the IPD and supporting information.

Locations

SA (1)